An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g
- Sponsor
- Genentech, Inc.
- Study ID
- NCT00109187
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Xolair (omalizumab) — DRUG
Study Details
This is a Phase IIIb, multicenter, open-label, extension study available to subjects who successfully complete Study Q2143g and have not participated in Study Q2195g. Subjects should be registered via the IVRS (Interactive Voice Response System) within 48 hours prior to their baseline visit. All subjects in this study will be treated with Xolair for 24 weeks. Subjects in the New Treatment Group may require additional visits for study drug injections (as frequently as every 2 weeks). Data collection during these additional visits will be limited to the assessment of adverse events. The study will evaluate all serious and nonserious adverse events, laboratory assessments, data on asthma exacerbations, and concomitant medication usage.
Key Dates
- Start date
- Jun 30, 2002
- Status verified
- Jun 2013
- Completion
- Apr 30, 2003
Study Design
- Enrollment
- 0 participants
- Primary purpose
- TREATMENT
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